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Transition to new GMP requirements for medicinal products

A notice about the implications of adopting PE009-13

21 November 2017

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A notice about adoption of a new PIC/S guide to GMP

The TGA will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for medicines and active pharmaceutical ingredients. This document is available from the TGA website, and will take effect on 1 January 2018 as communicated on 13 September 2017.

This will replace the manufacturing principles adopted in 2010 by the TGA for the manufacture of medicines, active pharmaceutical ingredients and sunscreens: the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-8.

This notice is being issued to assist with the transition period. It is a point-in-time document and we are not planning on updating this notice.

We will be updating GMP guidance during 2018 to reflect the new requirements.

Who this notice is for

This notice is intended for Australian sponsors and manufacturers of medicines and active pharmaceutical ingredients supplied in Australia.

The PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP) applies to the manufacture of the following (unless exempt under provisions in the therapeutic goods legislation):

  • Active Pharmaceutical Ingredients (APIs)
  • Registered (AUSTR) and Listed (AUSTL) medicines (including sunscreens)
  • Medicinal gases
  • Biologicals that comprise or contain live animal cells, tissues or organs

This notice is not applicable to medical device manufacturers or sponsors, or manufacturers, of human blood, blood components, haematopoietic progenitor cells (HPCs) or biologicals that comprise, contain or are derived from human cells and tissues.

Updates to the PIC/S guide to Good Manufacturing Practice for Medicinal Products (PE009)

There have been a number of updates to the PIC/S Guide to Good Manufacturing Practice since the publication of the January 2009 version (PE009-8), which is the most recent applicable standard adopted by TGA. The Revision history 2009 to 2017 table below details these revisions.

The majority of the updates clarified existing GMP regulatory expectations. However, with improved clarification, some manufacturers may require to implement and/or modify operational processes and procedures to maintain compliance. These changes are identified in the summary of new and amended requirements tables.

Revision history 2009 to 2017
Date Version number Reasons for revision
15 January 2009 PE 009-8
  • Revision of Chapter 1 (Part I)
  • Revision of Annex 1
  • New Annex 20
1 September 2009 PE 009-09
  • Revision of Annex 3
1 January 2013 PE 009-10
  • Revision of Chapter 4 (Part I)
  • Revision of Annexes 6, 7, 11 & 13
1 March 2014 PE009-11

Revision of Part II of the Guide to include:

  • Quality Risk Management
  • Revision of Annex 2
  • Revision of Annex 14
30 September 2015 PE009-12
  • Revision of Annex 15
1 January 2017 PE009-13
  • Revision of Chapters 1, 2, 6 & 7 (Part I)

Feedback

If you have any questions or feedback regarding the adoption of the PIC/S Guide to GMP, PE009-13, contact the Manufacturing Quality Branch (MQB).

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